FDA Grants Priority Review for OPNT003 Nasal Nalmefene to Treat Opioid Overdose

The FDA has accepted for Priority Review the New Drug Application for Opiant Pharmaceutical’s OPNT003, an intranasal formulation containing the high-affinity opioid antagonist nalmefene, for the treatment of opioid overdose. The investigational treatment is being developed as an alternative to naloxone for reversing the effects of opioids, such as respiratory depression, sedation, and hypotension. The FDA has previously granted Fast Track designation to OPNT003 for this indication.

Publish Date: 19-01-2023 Source: Opiant Pharmaceuticals

An opioid overdose occurs when a person has excessive unopposed stimulation of the opiate pathway. This can lead to decreased respiratory effort and possibly death. The frequency of opioid overdose is rapidly increasing. Opiates are frequently prescribed for moderate to severe pain in the US. They are often prescribed alone or in combination with non-steroidal anti-inflammatory drugs or muscle relaxants. Opioids work via the endogenous opioid system by acting as a potent agonist to the mu receptor. This results in a complex cascade of intracellular signals resulting in dopamine release, blockade of pain signals, and a resulting sensation of euphoria. Opioid receptors are located in the brain, spinal cord, and gut. In overdose, there is an excessive effect on the portion of the brain regulating respiratory rate, resulting in respiratory depression and eventually death.

In the USA, ~465,000 visits to the emergency rooms related to opiates in 2019. However, more than 20 MN population of the USA having exposed to opium.

However, the current Opioid Overdose treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Naloxone AP003, FMXIN001, etc.) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Opioid Overdose treatment. The key companies in the advanced development stage are Emergent BioSolutions, Nasus Pharma, etc.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Opioid Overdose to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

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